Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: Haloperidol; Haloperidol decanoate; Ketamine; Midazolam

Criteria

Inclusion Criteria:

• adult patient older than 18, who need to sedate in Emergency Department

Exclusion Criteria:

• age younger than 18 years,

• patients with significant cardiovascular disease,congestive heart failure (CHF)

• central nervous system lesions or injuries, increased intracranial pressure (ICP)

• ocular pathology, increased intraocular pressure (IOP)

• thyroid disease,

• acute pulmonary infections,

• conditions requiring stimulation of the posterior pharynx,

• had ingested solid food in the previous 4 hours or clear liquids in the previous 2 hours.

• Acute intermittent porphyria

• Alcoholism

• Hepatic Impairment

• Myasthenia gravis

• Respiratory depression

• allergy to haloperidol as established by direct questioning of family members and available medical history,

• moderate to severe dementia as documented by medical history,

• Parkinson's disease,

• corrected QTc interval (QTc) greater than 500 ms,

• usage of drugs prolonging QT-interval,

• history of torsades de pointes,

• history of neuroleptic malignant syndrome,

• family history of dystonic reactions to drugs,

• epilepsy or history of seizures

• chronic psychiatric disease,

• intoxication

• bone marrow suppression

• pregnancy